A Double-Blind, Placebo Controlled Trial of an Experimental Medication For the Treatment of Generalized Anxiety Disorder
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Jazz Pharmaceuticals
- Enrollment
- 511
- Locations
- 99
- Primary Endpoint
- Change in HAM-A Total Score
Study Overview
Brief Summary
The purpose of this study is to determine whether an experimental anti-anxiety medication is effective in the treatment of Generalized Anxiety Disorder.
Detailed Description
Protocol 04-001-01
The primary objective of the study is to assess, under controlled conditions, the safety and efficacy of an experimental anti-anxiety medication relative to placebo in subjects with generalized anxiety disorder (GAD).
The secondary objective of the study is to study algorithms for discontinuation of an experimental anti-anxiety medication.
Recruiting: Participants are currently being recruited and enrolled.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects 18 to 65 years of age will be eligible to participate if they satisfy the DSM-IV-TR criteria for the diagnosis of GAD.
Exclusion Criteria
- •No other primary psychiatric diagnosis besides GAD.
Outcomes
Primary Outcomes
Change in HAM-A Total Score
Time Frame: Baseline to week 8
Hamilton Anxiety Rating Scale (HAM-A). Each of 14 symptoms categories is rated from 0=not present to 4=very severe. Numbers for all categories are summed to produce the total score. Total score ranges from 0=anxiety symptoms not present to 56=very severe anxiety symptoms across all 14 categories.
Secondary Outcomes
No secondary outcomes reported